The present invention generally relates to electrosurgical systems and methods for ablating, severing, dissecting, contracting, or otherwise modifying target tissues or organs. The invention relates more particularly to electrosurgical apparatus and methods for modifying a tissue or organ via molecular dissociation of tissue components, wherein the apparatus includes an active electrode in the form of a plasma blade or hook. The present invention further relates to electrosurgical instruments and methods for harvesting blood vessels such as the internal mammary artery, the saphenous vein, or the like, for use in coronary artery bypass graft procedures.
Conventional electrosurgical instruments and techniques are widely used in surgical procedures because they generally reduce patient bleeding and trauma associated with cutting operations, as compared with mechanical cutting and the like. Conventional electrosurgical procedures may be classified as operating in monopolar or bipolar mode. Monopolar techniques rely on external grounding of the patient, where the surgical device defines only a single electrode pole. Bipolar devices have two electrodes for the application of current between their surfaces. Conventional electrosurgical devices and procedures, however, suffer from a number of disadvantages. For example, conventional electrosurgical cutting devices typically operate by creating a voltage difference between the active electrode and the target tissue, causing an electrical arc to form across the physical gap between the electrode and the tissue. At the point of contact of the electric arcs with the tissue, rapid tissue heating occurs due to high current density between the electrode and the tissue. This high current density causes cellular fluids to rapidly vaporize into steam, thereby producing a xe2x80x9ccutting effectxe2x80x9d along the pathway of localized tissue heating. Thus, the tissue is parted along the pathway of evaporated cellular fluid, inducing undesirable collateral tissue damage in regions surrounding the target tissue.
Further, monopolar electrosurgical devices generally direct electric current along a defined path from the exposed or active electrode through the patient""s body to the return electrode, the latter externally attached to a suitable location on the patient. This creates the potential danger that the electric current will flow through undefined paths in the patient""s body, thereby increasing the risk of unwanted electrical stimulation to portions of the patient""s body. In addition, since the defined path through the patient""s body has a relatively high electrical impedance, large voltage differences must typically be applied between the return and active electrodes in order to generate a current suitable for ablation or cutting of the target tissue. This current, however, may inadvertently flow along body paths having less impedance than the defined electrical path, which will substantially increase the current flowing through these paths, possibly causing damage to or destroying surrounding tissue.
Bipolar electrosurgical devices have an inherent advantage over monopolar devices because the return current path does not flow through the patient. In bipolar electrosurgical devices, both the active and return electrode are typically exposed so that both electrodes may contact tissue, thereby providing a return current path from the active to the return electrode through the tissue. One drawback with this configuration, however, is that the return electrode may cause tissue desiccation or destruction at its contact point with the patient""s tissue. In addition, the active and return electrodes are typically positioned close together to ensure that the return current flows directly from the active to the return electrode. The close proximity of these electrodes generates the danger that the current will short across the electrodes, possibly impairing the electrical control system and/or damaging or destroying surrounding tissue.
In addition, conventional electrosurgical methods are generally ineffective for ablating certain types of tissue, and in certain types of environments within the body. For example, loose or elastic connective tissue, such as the synovial tissue in joints, is extremely difficult (if not impossible) to remove with conventional electrosurgical instruments because the flexible tissue tends to move away from the instrument when it is brought against this tissue. Since conventional techniques rely mainly on conducting current through the tissue, they are not effective when the instrument cannot be brought adjacent to, or in contact with, the elastic tissue for a sufficient period of time to energize the electrode and conduct current through the tissue.
A prevalent form of cardiovascular disease is atherosclerosis in which the cardiovascular system leading to the heart is damaged or obstructed as a result of occluding material in the blood stream. Vascular complications produced by atherosclerosis, such as stenosis, aneurysm, rupture, or occlusion, increase the likelihood of angina, stroke, and heart attacks. In many cases, the obstruction of the blood stream leading to the heart can be treated by a coronary artery bypass graft (CABG) procedure.
In a conventional CABG procedure, the obstruction is bypassed by a vascular conduit established between an arterial blood source and the coronary artery to a location beyond the obstruction. The vascular conduit is typically a non-critical artery or vein harvested from elsewhere in the body. In a procedure known as xe2x80x9cfree bypass graftxe2x80x9d, the saphenous vein is harvested from the patient""s leg and is used as the vascular conduit. One end of the saphenous vein is anastomosed to the aorta and the other end is anastomosed to the diseased coronary artery at a location past the obstruction. In a procedure known as xe2x80x9cin situ bypass graftxe2x80x9d, an internal mammary artery (IMA) is used as the bypass conduit. In an in situ bypass graft procedure, the surgeon dissects a sufficient length of the artery from its connective tissue, then transects the artery and connects the transected end to the diseased coronary past the obstruction, and leaves the other end of the IMA attached to the arterial supply.
The internal mammary arteries are particularly desirable for use as in situ bypass grafts, as they are conveniently located, have diameters and blood flow volumes that are comparable to those of coronary arteries, and have superior patency rates. Use of the left or right IMA as a bypass graft first involves harvesting the IMA from the inside chest wall.
In conventional CABG procedures, access to the IMA is typically obtained either through a sternotomy or a gross thoracotomy. In the sternotomy or gross thoracotomy, the surgeon typically uses a saw or other cutting instrument to cut the sternum longitudinally to allow two opposing halves of the anterior portion of the rib cage to be spread apart. The opening into the thoracic cavity is created so that the surgeon may directly visualize the heart and thoracic cavity. However, such methods suffer from numerous drawbacks. For example, the longitudinal incision in the sternum often results in bone bleeding, which is difficult to stop. The bone bleeding can produce a high degree of trauma, a larger risk of complications, an extended hospital stay, and a painful recovery period for the patient. Once the surgeon has accessed the thoracic cavity, the conventional method of harvesting the IMA involves the use of scalpels or conventional electrosurgical devices. A number of disadvantages inherent in conventional electrosurgical devices have been set forth hereinabove.
Thus, there is a need for an electrosurgical apparatus which can be used for the precise removal or modification of tissue at a specific location, wherein a target tissue or organ can be dissected, transected, incised, contracted, and/or coagulated, with minimal, or no, collateral tissue damage. The instant invention provides such an apparatus and related methods, wherein tissue may be ablated or otherwise modified by a first region or element of a blade active electrode, and the modified tissue can be further modified by a second region or element of the blade active electrode, and wherein the quantity and quality of the tissue modification can be accurately controlled.
The present invention generally provides systems, apparatus, and methods for selectively applying electrical energy to cut, incise, ablate, or otherwise modify a tissue or organ of a patient. In one aspect, the electrosurgical systems and methods of the invention are useful for harvesting and dissecting veins and arteries of a patient, such as the saphenous vein or an IMA for use in a CABG procedure.
In one aspect, the present invention provides a method of creating an incision in a body structure. An electrosurgical probe is positioned adjacent the target tissue so that one or more active electrode(s) are brought into at least partial contact or close proximity with the target tissue. High frequency voltage is then applied between the active electrode(s) and one or more return electrode(s) and the active electrode(s) are moved, translated, reciprocated, or otherwise manipulated to cut through a portion of the tissue. In some embodiments, an electrically conductive fluid, e.g., isotonic saline or conductive gel, is delivered or applied to the target site to substantially surround the active electrode(s) with the fluid. In other embodiments, the active electrode(s) are immersed within the electrically conductive fluid. In both embodiments, the high frequency voltage may be selected to locally ablate or sever a target tissue, and/or to effect a controlled depth of hemostasis of severed blood vessels within the tissue. In another aspect, the electrosurgical systems and methods of the invention are useful for harvesting and dissecting veins and arteries of a patient, such as the saphenous vein or the IMA for use in a CABG procedure.
In one aspect, tissue is cut or otherwise modified by molecular dissociation or disintegration processes. (In contrast, in conventional electrosurgery tissue is cut by rapidly heating the tissue until cellular fluids explode, producing a cutting effect along the pathway of localized heating.) The present invention volumetrically removes the tissue along the cutting pathway in a cool ablation process that minimizes thermal damage to surrounding tissue. In these embodiments, the high frequency voltage applied to the active electrode(s) is sufficient to vaporize the electrically conductive fluid (e.g., gel or saline) between the active electrode(s) and the tissue. Within the vaporized fluid, a plasma is formed and charged particles (e.g., electrons) cause the molecular breakdown or disintegration of the tissue, perhaps to a depth of several cell layers. This molecular dissociation is accompanied by the volumetric removal of the tissue, e.g., along the incision of the tissue. This process can be precisely controlled to effect the volumetric removal of tissue as thin as 10 microns to 150 microns with minimal heating of, or damage to, surrounding or underlying tissue structures. A more complete description of this phenomenon is described in commonly assigned U.S. Pat. No. 5,683,366, the complete disclosure of which is incorporated herein by reference.
In a specific embodiment, the present invention provides a method of accessing a patient""s thoracic cavity. The active electrode(s) are positioned in contact or in close proximity to a surface of the sternum. A high frequency voltage is applied between the active electrode(s) and a return electrode. The active electrodes are moved across the sternum to create an incision. In a specific configuration, the sides of the active electrode are slidingly engaged with the sternum as the incision is being made, so as to cause coagulation and hemostasis within the sternum.
In another exemplary embodiment, the present invention provides a method for harvesting the IMA from a patient. The electrosurgical probe is positioned adjacent the IMA and high frequency electrical energy is applied between one or more active electrode(s) and one or more return electrode(s). The probe is then moved so that the active electrode(s) volumetrically removes connective tissue adjacent to the IMA so that the IMA is free from connective tissue along a portion of its length. In an exemplary embodiment, the probe is positioned adjacent to the IMA, and advanced along the length of the IMA while high frequency electrical energy is applied between the active electrode(s) and a return electrode to remove or cut the connective tissue or other structures surrounding the IMA. The residual heat from the electrical energy also provides simultaneous hemostasis of severed blood vessels, which increases visualization and improves recovery time for the patient. In addition, the ability to simultaneously cut through tissue on either side of the IMA decreases the length of the procedure, which further improves patient recovery time. After a suitable length of the IMA has been dissected, it may be transected, and anastomosed to a diseased coronary artery using known methods. In some embodiments, an electrically conductive fluid (liquid, gas, or gel) is placed at the target site adjacent to the IMA so as to provide a current flow path between the return electrode and the active electrode.
Apparatus according to the present invention generally include an electrosurgical instrument, such as a probe or catheter, having a shaft with proximal and distal ends, one or more active electrode(s) at the distal end and one or more connectors coupling the active electrode(s) to a source of high frequency electrical energy. The active electrode(s) are preferably designed for cutting tissue; i.e., they typically have a distal edge or point. In one embodiment, a plurality of active electrodes are aligned with each other to form a linear electrode array for cutting a path through the tissue. In another exemplary embodiment, the active electrode(s) include a sharp distal point to facilitate the cutting of the target tissue. In one specific configuration, the active electrode is a blade having a sharp distal point and sides. As the sharp distal point incises the tissue, the sides of the blade slidingly contact the incised tissue. The electrical current flows through that portion of the tissue in the vicinity of the active electrode and/or the conductive fluid to the return electrode, such that the target tissue is first severed, and then the severed tissue is coagulated.
The apparatus can further include a fluid delivery element for delivering electrically conductive fluid to the active electrode(s) and the target site. The fluid delivery element may be located on the probe, e.g., a fluid lumen or tube, or it may be part of a separate instrument. Alternatively, an electrically conductive gel or spray, such as a saline electrolyte or other conductive gel, may be applied the target site. In this embodiment, the apparatus may not have a fluid delivery element. In both embodiments, the electrically conductive fluid preferably provides a current flow path between the active electrode(s) and one or more return electrode(s). In an exemplary embodiment, the return electrode is located on the probe and spaced a sufficient distance from the active electrode(s) to substantially avoid or minimize current shorting therebetween and to shield the return electrode from tissue at the target site.
In a specific configuration, the electrosurgical probe includes an electrically insulating electrode support member having a tissue treatment surface at the distal end of the probe. One or more active electrode(s) are coupled to, or integral with, the electrode support member such that the active electrode(s) are spaced from the return electrode. In one embodiment, the probe includes a plurality of active electrode(s) having distal edges linearly aligned with each other to form a sharp cutting path for cutting tissue. The active electrodes are preferably electrically isolated from each other, and they extend about 0.2 mm to about 10 mm distally from the tissue treatment surface of the electrode support member. In this embodiment, the probe may further include one or more lumens for delivering electrically conductive fluid to one or more openings around the tissue treatment surface of the electrode support member. In an exemplary embodiment, the lumen extends through a fluid tube exterior to the probe shaft that ends proximal to the return electrode.
In another aspect of the invention, the electrode support member comprises a plurality of wafer layers bonded together, e.g., by a glass adhesive or the like. The wafer layers each have conductive strips plated or printed thereon to form the active electrode(s) and the return electrode(s). In one embodiment, the proximal end of the wafer layers will have a number of holes extending from the conductor strips to an exposed surface of the wafer layers for connection to electrical conductor lead traces in the electrosurgical probe or handpiece. The wafer layers preferably comprise a ceramic material, such as alumina, and the electrode will preferably comprise a metallic material, such as gold, platinum, tungsten, palladium, silver or the like.
In another aspect of the invention, there is provided an electrosurgical probe having a blade-like active electrode affixed to an electrically insulating electrode support on the distal end of a shaft. In a specific configuration, the active electrode is in the form of a plasma blade comprising a substantially flat metal blade having at least one active edge and first and second blade sides. In one embodiment, the active electrode comprises a hook. The hook may include a curved portion. One or more portions of the hook may have a serrated edge. The return electrode is typically located on the shaft distal end proximal to the electrode support. In use, the active electrode and the return electrode are coupled to opposite poles of a high frequency power supply. The active edge may have a variety of shapes, and is adapted for generating high current densities thereon, and for precisely severing or ablating tissue or an organ in a highly controlled manner via molecular dissociation of tissue components. The first and second blade sides are adapted for engaging with tissue, such as tissue severed by the active edge, and for coagulating tissue engaged therewith.
The probe may be provided in various configurations, for example, according to a particular procedure to be performed. Thus, the electrode support may be arranged terminally or laterally on the probe, and the blade active electrode may be arranged terminally or laterally on the electrode support. The active electrode may be provided in various forms, such as a metal blade of unitary construction, e.g., a metal disc or portion thereof, a crosspiece supported by at least one electrode arm, or a hook. The shaft distal end may have a beveled end, a distal curve, and/or a laterally compressed region. Each of these features or elements of the probe may facilitate accessing a tissue or organ targeted for treatment or modification by the probe. In addition, the laterally compressed region may be adapted for accommodating the electrode support.
According to one aspect of the invention, there is provided a method for modifying a tissue using an electrosurgical probe having an active electrode in the form of a single blade which includes at least one active edge and first and second blade sides. The method involves positioning the probe such that the active electrode makes contact with, or is in close proximity to, a target tissue; and applying a high frequency voltage between the active and return electrodes sufficient to precisely sever or remove target tissue via molecular dissociation of tissue components adjacent to the active edge. The probe may be manipulated during the application of the high frequency voltage such that the active electrode is moved with respect to the target tissue. According to one aspect of the invention, the configuration of the active electrode (e.g., a hook shaped electrode) is adapted for severing tissue as the probe distal end is drawn or pulled towards the operator of the probe. In this manner, the extent to which the tissue is severed can be precisely controlled. Thereafter, the severed tissue may be coagulated upon engagement of the tissue against the first and second blade sides of the active electrode.
In another aspect of the invention, there is provided a method of harvesting a tissue or organ using an electrosurgical probe having an active electrode in the form of a single blade, wherein the single blade electrode includes an active edge and first and second blade sides. In situations where the tissue to be harvested is concealed by an overlying tissue, the tissue to be harvested must first be accessed by incising or removing the overlying tissue. Removal of the overlying tissue may be performed in various ways, including: 1) mechanically, e.g. using a scalpel, rongeur, surgical saw or drill, etc. or a combination thereof; 2) via conventional electrosurgery, e.g., a Bovie; or 3) using an electrosurgical probe of the instant invention adapted for severing tissue in a cool ablation process. Once the tissue or organ to be harvested is accessible, the tissue or organ to be harvested may be dissected by juxtaposing the active edge of the active electrode against the surrounding connective tissue, and applying a high frequency voltage between the active and return electrodes sufficient to cause molecular dissociation of connective tissue components. In this way, the connective tissue adjacent to the active electrode is ablated at a temperature in the range of 40xc2x0 C. to 70xc2x0 C., with no, or minimal, thermal damage to the tissue to be harvested.
The electrosurgical probe of the invention is also applicable to a broad range of other procedures, including without limitation: cutting, resection, ablation, and/or hemostasis of tissues and organs such as prostate tissue, scar tissue, myocardial tissue, and tissues of the knee, shoulder, hip, and other joints; procedures of the head and neck, such as of the ear, mouth, throat, pharynx, larynx, esophagus, nasal cavity, and sinuses; as well as procedures involving skin tissue removal and/or collagen shrinkage in the epidermis or dermis. A more detailed account of various treatments and procedures which may be carried out according to the invention is set forth in enabling detail hereinbelow.
For a further understanding of the nature and advantages of the invention, reference should be made to the following description taken in conjunction with the accompanying drawings.